Evaluation of gynecological and dermatological acceptability of health products using the product at home

Not Applicable

• Conditions: Healthy volunteers; M01.774

• Registration Number: RBR-7gsnvdv
• Lead Sponsor: Avenca Indústria Cosmética Eireli -EPP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-21
• Study Completion: 2022-10-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Women; age: 18 to 59 years; phototype: I to IV; whole skin of the region; occasional user of category products

Exclusion Criteria

Skin tags in the experimental area that interfere in the evaluation of possible reactions; Pregnant or lactating women; Participants with a history of allergy to the material used in the study; Atopy history; Use of vaginal cream; Participants with a history of allergy to products in the tested category; Recent gynecological surgeries; discharges; Immunodeficiency carriers; Kidney, heart or liver transplants; Active skin pathologies that may interfere with the study (vitiligo, psoriasis, lupus, atopic dermatitis); Topical use with corticosteroids in the experimental area up to 8 days before the start of the study.; Any condition not mentioned above that, in the opinion of the investigator, could compromise the evaluation of the study

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected to verify the acceptability of the investigational product, an intimate lubricant, in the studied population, after using the products in real conditions of use, through dermatological and gynecological medical evaluation of clinical signs and feelings of discomfort, based on the finding of that none of the participants presented discomfort or clinical signs, considering the product as gynecologically and dermatologically tested.

Secondary Outcome Measures

Name	Time	Method
It is expected to guarantee the safety of the product, an intimate lubricant, to the end users, based on the observation that none of the participants presented discomfort or clinical signs.